A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00001032 |
|
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: March 30, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.
SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine Drug: Zalcitabine | Phase 2 |
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 180 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection |
| Actual Study Completion Date : | April 1995 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Recommended:
- PCP prophylaxis.
Allowed:
- Intravenous and/or intramuscular immunoglobulin.
- Acyclovir (no more than 30 mg/kg/day PO).
- Ketoconazole (no more than 10 mg/kg/day).
- Nystatin.
- Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
- Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
- Trimethoprim / sulfamethoxazole.
- Amphotericin B (no more than 1 mg/kg for 5 days/week).
- Aerosolized ribavirin for bronchiolitis.
- Hematopoietic agents.
- Other drugs with little nephro-, hepato-, or cytotoxicity.
- Nutritional support for HIV wasting syndrome or malnutrition.
Patients must have:
- HIV infection.
- Ongoing stable AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
- Known allergy or sensitivity to ddC.
- Cardiomyopathy.
Concurrent Medication:
Excluded:
- Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
- Investigational medications unless approved by protocol chair.
- Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).
Patients with the following prior conditions are excluded:
- History of intolerance or toxicity to AZT.
- History of symptomatic pancreatitis.
- History of peripheral neuropathy or abnormal nerve conduction velocity test.
Prior Medication:
Excluded:
- Antiretroviral agents other than AZT within 2 weeks of study entry.
Required:
- Ongoing stable AZT therapy for more than 6 weeks duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001032
Hide Study Locations
| United States, California | |
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | |
| Long Beach, California, United States, 90801 | |
| Usc La Nichd Crs | |
| Los Angeles, California, United States, 90033 | |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | |
| Los Angeles, California, United States | |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | |
| Oakland, California, United States, 94609 | |
| UCSD Maternal, Child, and Adolescent HIV CRS | |
| San Diego, California, United States, 92093 | |
| San Francisco Gen. Hosp. | |
| San Francisco, California, United States, 94110 | |
| UCSF Pediatric AIDS CRS | |
| San Francisco, California, United States, 94143 | |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Univ. of Connecticut Health Ctr., Dept. of Ped. | |
| Farmington, Connecticut, United States, 06032 | |
| Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| Children's National Med. Ctr., ACTU | |
| Washington, District of Columbia, United States, 20010 | |
| Howard Univ. Washington DC NICHD CRS | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | |
| Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases | |
| Atlanta, Georgia, United States, 30306 | |
| United States, Illinois | |
| Cook County Hosp. | |
| Chicago, Illinois, United States, 60612 | |
| Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. | |
| Chicago, Illinois, United States, 60612 | |
| Chicago Children's CRS | |
| Chicago, Illinois, United States, 60614 | |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Tulane/LSU Maternal/Child CRS | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | |
| Boston, Massachusetts, United States, 02115 | |
| BMC, Div. of Ped Infectious Diseases | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Health, Baystate Med. Ctr. | |
| Springfield, Massachusetts, United States, 01199 | |
| WNE Maternal Pediatric Adolescent AIDS CRS | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Children's Hospital of Michigan NICHD CRS | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| UMDNJ - Robert Wood Johnson | |
| New Brunswick, New Jersey, United States | |
| St. Joseph's Hosp. & Med. Ctr. of New Jersey | |
| Paterson, New Jersey, United States | |
| United States, New York | |
| Children's Hospital at Albany Medical Center, Dept. of Peds. | |
| Albany, New York, United States, 12208 | |
| Bronx-Lebanon Hosp. IMPAACT CRS | |
| Bronx, New York, United States, 10457 | |
| SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS | |
| Brooklyn, New York, United States, 11203 | |
| North Shore-Long Island Jewish Health System, Dept. of Peds. | |
| Great Neck, New York, United States, 11021 | |
| Schneider Children's Hosp., Div. of Infectious Diseases | |
| New Hyde Park, New York, United States, 11040 | |
| NYU Med. Ctr., Dept. of Medicine | |
| New York, New York, United States, 10016 | |
| Metropolitan Hosp. NICHD CRS | |
| New York, New York, United States, 10029 | |
| Columbia IMPAACT CRS | |
| New York, New York, United States, 10032 | |
| Incarnation Children's Ctr. | |
| New York, New York, United States, 10032 | |
| Harlem Hosp. Ctr. NY NICHD CRS | |
| New York, New York, United States | |
| Univ. of Rochester ACTG CRS | |
| Rochester, New York, United States, 14642 | |
| SUNY Upstate Med. Univ., Dept. of Peds. | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| DUMC Ped. CRS | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| The Children's Hosp. of Philadelphia IMPAACT CRS | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| St. Christopher's Hosp. for Children | |
| Philadelphia, Pennsylvania, United States, 19134 | |
| United States, South Carolina | |
| Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Washington | |
| UW School of Medicine - CHRMC | |
| Seattle, Washington, United States, 98105 | |
| Puerto Rico | |
| Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. | |
| Bayamon, Puerto Rico, 00956 | |
| San Juan City Hosp. PR NICHD CRS | |
| San Juan, Puerto Rico, 00936 | |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | |
| San Juan, Puerto Rico, 00936 | |
| Study Chair: | S Pahwa | ||
| Study Chair: | SS Bakshi |
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001032 History of Changes |
| Other Study ID Numbers: |
ACTG 190 11165 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | March 30, 2012 |
| Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Additional relevant MeSH terms:
|
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Zidovudine Zalcitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |